Docstoc

AS ISO 109935-2002 Biological evaluation of medical devices Tests for in vitro cytotoxicity

Document Sample
AS ISO 109935-2002 Biological evaluation of medical devices Tests for in vitro cytotoxicity Powered By Docstoc
					                                                                                                                                    AS ISO 10993.5—2002
                                                                                                                                    ISO 10993-5:1999
                                                                                           AS ISO 10993.5




                                                                                                            Australian Standard™
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                                            Biological evaluation of medical devices

                                                                                                            Part 5: Tests for in vitro cytotoxicity
                                                                                           This Australian Standard was prepared by Committee HE-012, Surgical Implants. It
                                                                                           was approved on behalf of the Council of Standards Australia on 26 June 2002 and
                                                                                           published on 28 June 2002.




                                                                                           The following are represented on Committee HE-012:
                                                                                             Australian Chamber of Commerce and Industry
                                                                                             Australian College of Operating Room Nurses
                                                                                             Australian Dental Association
                                                                                             Australian Industry Group
                                                                                             Australian Orthopaedic Association
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                             Commonwealth Department of Health and Ageing
                                                                                             Department of Defence (Australia)
                                                                                             Medical Industry Association of Australia Inc
                                                                                             Neurological Society of Australasia
                                                                                             Royal Australasian College of Surgeons
                                                                                             Royal Perth Hospital
                                                                                             The Australian Society for Biomaterials
                                                                                             The University of New South Wales
                                                                                             The University of Sydney




                                                                                                                    Keeping Standards up-to-date
                                                                                           Standards are living documents which reflect progress in science, technology and
                                                                                           systems. To maintain their currency, all Standards are periodically reviewed, and
                                                                                           new editions are published. Between editions, amendments may be issued.
                                                                                           Standards may also be withdrawn. It is important that readers assure themselves
                                                                                           they are using a current Standard, which should include any amendments which
                                                                                           may have been published since the Standard was purchased.
                                                                                           Detailed information about Standards can be found by visiting the Standards
                                                                                           Australia web site at www.standards.com.au and looking up the relevant Standard
                                                                                           in the on-line catalogue.
                                                                                           Alternatively, the printed Catalogue provides information current at 1 January each
                                                                                           year, and the monthly magazine, The Australian Standard, has a full listing of
                                                                                           revisions and amendments published each month.
                                                                                           We also welcome suggestions for improvement in our Standards, and especially
                                                                                           encourage readers to notify us immediately of any apparent inaccuracies or
                                                                                           ambiguities. Contact us via email at mail@standards.com.au, or write to the Chief
                                                                                           Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW
                                                                                           2001.




                                                                                                   This Standard was issued in draft form for comment as DR 02217.
                                                                                                                                                  AS ISO 10993.5—2002




                                                                                           Australian Standard™
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                           Biological evaluation of medical devices

                                                                                           Part 5: Tests for in vitro cytotoxicity




                                                                                           First published as AS ISO 10993.5—2002.




                                                                                           COPYRIGHT
                                                                                           © Standards Australia International
                                                                                           All rights are reserved. No part of this work may be reproduced or copied in any form or by any
                                                                                           means, electronic or mechanical, including photocopying, without the written permission of the
                                                                                           publisher.
                                                                                           Published by Standards Australia International Ltd
                                                                                           GPO Box 5420, Sydney, NSW 2001, Australia
                                                                                           ISBN 0 7337 4712 4
                                                                                                                                         ii



                                                                                                                                    PREFACE
                                                                                           This Standard has been developed to assist in the process of implementation of the
                                                                                           Australian Medical Device legislation.
                                                                                           After consultation with stakeholders in both countries, Standards Australia and Standards
                                                                                           New Zealand decided to develop this Standard as an Australian, rather than an
                                                                                           Australian/New Zealand Standard, through the Joint Standards Australia/Standards
                                                                                           New Zealand Committee HE-012 on Surgical Implants.
                                                                                           This Standard is identical with and has been reproduced from ISO 10993-5:1999, Biological
                                                                                           evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
                                                                                           The objective of this Standard is to specify requirements for test methods to assess the in
                                                                                           vitro cytotoxicity for biological evaluation of medical devices.
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                           As this Standard is reproduced from an international Standard, the following applies:
                                                                                           (a)   Its number does not appear on each page of text and its identity is shown only on the
                                                                                                 cover and title page.
                                                                                           (b)   In the source text ‘this International Standard’ should read ‘this Australian Standard’.
                                                                                           (c)   A full point substitutes for a comma when referring to a decimal marker.
                                                                                                                                                                                iii


                                                                                                                                                                     CONTENTS



                                                                                           1 Scope ........................................................................................................................................................................ 1

                                                                                           2 Normative references .............................................................................................................................................. 1

                                                                                           3 Terms and definitions ............................................................................................................................................. 1

                                                                                           4 Sample preparation ................................................................................................................................................. 2

                                                                                           5 Cell lines ................................................................................................................................................................... 4

                                                                                           6 Culture medium........................................................................................................................................................ 4
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                           7 Preparation of cell stock culture ............................................................................................................................ 4

                                                                                           8 Test procedures ....................................................................................................................................................... 5

                                                                                           9 Test report ................................................................................................................................................................ 8

                                                                                           10 Assessment of results........................................................................................................................................... 8
                                                                                                                                                          iv


                                                                                                                                                INTRODUCTION



                                                                                           Due to the general applicability of in vitro cytotoxicity tests and their widespread use in evaluating a large range of
                                                                                           medical devices and materials, it is the purpose of this part of ISO 10993, rather than to specify a single test, to
                                                                                           define a scheme for testing which requires decisions to be made in a series of steps. This should lead to the
                                                                                           selection of the most appropriate test.

                                                                                           Three categories of test are listed: extract test, direct-contact test, indirect-contact test.

                                                                                           The choice of one or more of these categories depends upon the nature of the sample to be evaluated, the potential
                                                                                           site of use and the nature of the use.

                                                                                           This choice then determines the details of the preparation of the samples to be tested, the preparation of the
                                                                                           cultured cells, and the way in which the cells are exposed to the samples or their extracts.
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                           At the end of the exposure time, the evaluation of the presence and extent of the cytotoxic effect is undertaken. It is
                                                                                           the intention of this part of ISO 10993 to leave open the choice of type of evaluation. Such a strategy makes
                                                                                           available a battery of tests, which reflects the approach of many groups which advocate in vitro biological tests.

                                                                                           The numerous methods used and end-points measured in cytotoxicity determination can be grouped into categories
                                                                                           of evaluation type:

                                                                                           a)   assessments of cell damage by morphological means;

                                                                                           b)   measurements of cell damage;

                                                                                           c)   measurements of cell growth;

                                                                                           d)   measurements of specific aspects of cellular metabolism.

                                                                                           There are, therefore, several alternative means of producing results in each of these four categories. The
                                                                                           investigator should be aware of the categories of test and into which a particular technique fits, in order that
                                                                                           comparisons may be made with other results on similar medical devices or materials, and in order that
                                                                                           interlaboratory tests may be conducted.
                                                                                                                                                       1


                                                                                              AUSTRALIAN STANDARD


                                                                                              Biological evaluation of medical devices

                                                                                              Part 5: Tests for in vitro cytotoxicity



                                                                                             1 Scope

                                                                                             This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.

                                                                                             These methods specify the incubation of cultured cells either directly or through diffusion
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                             a)   with extracts of a device, and/or
                                                                                             b)   in contact with a device.

                                                                                             These methods are designed to determine the biological response of mammalian cells in vitro using appropriate
                                                                                             biological parameters.


                                                                                             2 Normative references
                                                                                             The following normative documents contain provisions which, through reference in this text, constitute provisions of
                                                                                             this part of ISO 10993. For dated references, subsequent amendments to, or revisions of, any of these publications
                                                                                             do not apply. However, parties to agreements based on this part of ISO 10993 are encouraged to investigate the
                                                                                             possibility of applying the most recent editions of the normative documents indicated below. For undated
                                                                                             references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
                                                                                             registers of currently valid International Standards.

                                                                                             ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing.

                                                                                             ISO 10993-12:1996, Biological evaluation of medical devices — Part 12: Sample preparation and reference
                                                                                             materials.


                                                                                             3 Terms and definitions
                                                                                             For the purposes of this part of ISO 10993, the terms and definitions given in ISO 10993-1 and the following apply.

                                                                                             3.1
                                                                                             negative control material
                                                                                             material which, when tested in accordance with this part of ISO 10993, does not produce a cytotoxic response

                                                                                             NOTE       The purpose of the negative control is to demonstrate background response. For example, high-density poly-
                                                                                             ethylene1) for synthetic polymers, and aluminium oxide ceramic rods for dental material, have been used as negative controls.




                                                                                             1) High-density polyethylene can be obtained from the U.S. Pharmacopeia (Rockville, Maryland, USA) and Food and Drug
                                                                                             Safety Center, Hatano Research Institute (Ochiai 729-5, Hadanoshi, Kanagawa 257 - Japan). This information is given for the
                                                                                             convenience of the user of this part of ISO 10993 and does not constitute an endorsement by ISO of these products.




                                                                                           www.standards.com.au                                                                                 Standards Australia
                                                                                                   This is a free preview. Purchase the entire publication at the link below:




                                                                                                             AS ISO 10993.5-2002, Biological evaluation of
                                                                                                             medical devices Tests for in vitro cytotoxicity
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.




                                                                                              Looking for additional Standards? Visit SAI Global Infostore
                                                                                              Subscribe to our Free Newsletters about Australian Standards® in Legislation; ISO, IEC, BSI and more
                                                                                              Do you need to Manage Standards Collections Online?
                                                                                              Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation
                                                                                              Do you want to know when a Standard has changed?
                                                                                              Want to become an SAI Global Standards Sales Affiliate?

                                                                                           Learn about other SAI Global Services:

                                                                                              LOGICOM Military Parts and Supplier Database
                                                                                              Metals Infobase Database of Metal Grades, Standards and Manufacturers
                                                                                              Materials Infobase Database of Materials, Standards and Suppliers
                                                                                              Database of European Law, CELEX and Court Decisions




                                                                                                          Need to speak with a Customer Service Representative - Contact Us

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:25
posted:7/10/2012
language:Latin
pages:8
SAIGlobalAPAC SAIGlobalAPAC http://
About